Live Better Triple Antibiotic Plus Pain Relief (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride) Ointment [The Great Atlantic & Pacific Tea Company] -

LIVE BETTER TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [THE GREAT ATLANTIC & PACIFIC TEA COMPANY]
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NDC	51143-027-02
Set ID	7e7a0b4c-67a9-42f3-aacd-2606fde25090
Category	HUMAN OTC DRUG LABEL
Packager	The Great Atlantic & Pacific Tea Company
Generic Name
Product Class	Aminoglycoside Antibacterial
Product Number
Application Number	PART333B

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SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (each gram contains)	Purpose
Bacitracin zinc 500 units	First aid antibiotic
Neomycin sulfate 3.5 mg	First aid antibiotic
Polymyxin B sulfate 10,000 units	First aid antibiotic
Pramoxine hydrochloride 10 mg	External analgesic

Uses
first aid to help prevent infection and for the temporary relief of pain or discomfort in minor:
- cuts
- scrapes
- burns
Warnings
For external use only.
Do not use
- in the eyes
- over large areas of the body
- if you are allergic to any of the ingredients
Ask a doctor before use if you have
- deep or puncture wounds
- animal bites
- serious burns
Stop use and ask a doctor if
- condition persists or gets worse
- you need to use longer than 1 week
- symptoms persist for more than 1 week, or clear up and occur again within a few days
- a rash or other allergic reaction develops
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Adults and children 2 years of age and older:
  - clean the affected area and dry thoroughly
  - apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
  - may be covered with a sterile bandage
- Children under 2 years of age: ask a doctor
Other information
- To open: unscrew cap, pull tab to remove foil seal
- store at 20° to 25°C (68° to 77°F)
- see carton or tube crimp for lot number and expiration date
Inactive ingredient

white petrolatum
Questions?

Call 1-866-923-4914
SPL UNCLASSIFIED SECTION

DISTRIBUTED BY ONPOINT, INC.
2 PARAGON DRIVE,
MONTVALE, NJ 07645
PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

Maximum Strength

Triple Antibiotic Ointment + Pain Relief

■ BACITRACIN ZINC ■ NEOMYCIN SULFATE ■ POLYMYXIN B SULFATE ■ PRAMOXINE HYDROCHLORIDE

First Aid Antibiotic / Pain Relieving Ointment

NET WT 1 OZ (28.4g)

INGREDIENTS AND APPEARANCE

LIVE BETTER TRIPLE ANTIBIOTIC PLUS PAIN RELIEF
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51143-027
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I)	Bacitracin	500 [iU] in 1 g
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297)	Neomycin	3.5 mg in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K)	Polymyxin B	10000 [iU] in 1 g
Pramoxine hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056)	Pramoxine hydrochloride	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
petrolatum (UNII: 4T6H12BN9U)

#	Item Code	Package Description
Packaging
1	NDC:51143-027-02	1 in 1 CARTON
1		28.4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	03/31/2012

Labeler - The Great Atlantic & Pacific Tea Company (001367366)

Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Name	Address	ID/FEI	Business Operations
Establishment
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(51143-027)

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Medic

LIVE BETTER TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [THE GREAT ATLANTIC & PACIFIC TEA COMPANY]

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

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